Status:
COMPLETED
Study of TLK199 Tablets in Myelodysplastic Syndrome (MDS)
Lead Sponsor:
Telik
Conditions:
Myelodysplastic Syndrome (MDS)
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to determine the safety and efficacy of TLK199 Tablets in patients with Myelodysplastic Syndrome (MDS)
Detailed Description
This Phase 1-2a study is an open label, dose-ranging study of TLK199 Tablets in patients with all World Health Organization or French-American-British classification types of myelodysplastic syndrome ...
Eligibility Criteria
Inclusion
- Histologically confirmed diagnosis of MDS
- Documented significant cytopenia for at least 2 months
- Adequate liver and kidney function
- Ineligible for stem cell bone marrow transplantation
- At least 18 years of age
- Discontinuation of growth factors (e.g., G-CSF) within 3 weeks of study entry
Exclusion
- Prior bone marrow transplant
- Failure to recover from any prior surgery or any major surgery within 4 weeks of study entry
- Pregnant or lactating women
- Other investigational drugs within 14 days of study entry
- Chemotherapy, radiotherapy or immunotherapy within 14 days of study entry
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT00280631
Start Date
February 1 2006
End Date
June 1 2008
Last Update
May 31 2012
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Loyola University Chicago-Cardinal Bernardin Cancer Center
Maywood, Illinois, United States, 60153
2
Loyola University Medical Center
Maywood, Illinois, United States, 60153
3
University of Massachusetts (UMass) Memorial Medical Center
Worcester, Massachusetts, United States, 01655